The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), will do the checks to review the compliance status of MSME drug firms’ good manufacturing practices (GMP), the people added.
“Right now, DCGI is still getting applications as the deadline is open,” the first official said. “Only after the deadline, the government will conduct random checks at these MSME drug makers to verify whether they are meeting GMP requirement or not. Strict actions including notices and cancellation of the licence will be taken against the manufacturers found non-compliant.”
“This exercise would be done at the end of this year, but how this plan would be executed is yet to be designed,” the second official cited above said. “State governments may be roped in.”
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Notably, this January, the Centre extended the deadline to 31 December 2025 for MSME companies to upgrade their facilities, with the previous deadline ending on 31 December 2024.
The stringent action is meant to prevent criticism of quality of drugs produced in the country and to prevent any non-tariff barriers to Indian drug exports. Entities found to be non-compliant will face strict action including closure of their factories.
The first official added that MSME drug firms that want an extension to upgrade their plants have to do a gap analysis in areas like lab equipment, utilities, technical staff, HVAC (heating, ventilation, and air conditioning) systems. “The companies will also have to justify why they need extension,” this person said.
Industry sources said that less than 10 MSME drug firms have filed applications before the DCGI seeking extension in the timeline to upgrade their plants.
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According to government estimates, only 2,000 pharmaceutical manufacturing units in India have the GMP certification, mostly comprising large companies (with revenue more than ₹250 crore), and with a sprinkling of MSMEs.
The remaining drug makers, which add up to 8,500 MSMEs, are yet to upgrade their plants to standards set by the WHO (World Health Organization). To be sure, the MSME drug manufacturing units comprise more than 80% of the market by volume in India.
Queries sent to the union health ministry spokesperson remained unanswered.
Right now, MSME drug firms, which have annual turnover of ₹250 crore or less, are under the radar of the government to comply with the GMP rules.
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Harish Jain, president of the Federation of Pharmaceutical Entrepreneurs (FOPE), an association of MSME drug firms said, “At FOPE, we are motivating our member companies to upgrade their facilities, which is the opportunity to upgrade our business. We are educating them on how to file the application. With our efforts, we got the extension for one year and on 16 March, we organized a workshop with the drug companies to motivate them to register for GMP compliance.”
What is GMP?
Good manufacturing practices or GMP are being implemented in the country to bring quality into products by way of control on materials, methods, machines, processes, personnel and facility or environment. In 2023, the government notified revised Schedule M of the Drugs and Cosmetics Rules, 1945, which prescribes GMP standards for drug firms.
In the first phase, drugmakers with an annual turnover of ₹250 crore and above were to compulsorily follow GMP within six months from the date of notification, while the smaller firms were given a year to comply.
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India drug making hubs include Himachal Pradesh, Madhya Pradesh, Hyderabad, Maharashtra and Gujarat, which fall under the regulatory radar of the State and the Central Drug Licensing Authority.
According to the department of pharmaceuticals, India is the world’s largest supplier of generic medicines. The country manufactures about 60,000 generic drugs across 60 therapeutic categories, accounting for 20% of the global supply of generic drugs.
Earlier Mint reported that under the DoP’s Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS), around 103 applications from MSME drug firms have been sanctioned for total financial support amounting to ₹105 crore on reimbursement basis.
Source:https://www.livemint.com/politics/policy/drug-makers-manufacturing-norms-dcgi-msme-drug-firms-non-tariff-barriers-generic-drugs-gmp-11742385224371.html